This study will evaluate immune function in people with a known or suspected immune disorder.
It will determine participants immune response to vaccines by measuring blood antibody levels
Patients enrolled in a NIH protocol involving immune reconstitution (bone marrow
transplantation or gene therapy) for a known or suspected primary immune disorder may be
eligible for this study.
Participants may be asked to have more than one vaccine, based on their age, use of IVIG,
past immunization history and underlying immune problem. The possible vaccinations include:
Diphtheria and tetanus booster
23 valent pneumococcal polysaccharide vaccine
Pneumococcal 7-valent conjugate vaccine
The diphtheria, tetanus, pneumococcus and rabies vaccines are approved by the Food and Drug
Administration (FDA) and used routinely to protect against disease.
Study participants will have a blood sample drawn before vaccination. The number of
additional samples collected will vary according to the vaccines administered; 1 for rabies;
1 for tetanus; and 1 to 2 for the pneumococcal vaccines. Each sample will be up to 5
teaspoonfuls. Participation in the study may last up to a year, depending on the blood
The purpose of this study is to evaluate immune responses to vaccines in subjects (both
children and adults) with known or suspected primary immune disorders. We intend to
characterize immune responsiveness to standard, well characterized antigens (vaccines) in
subjects with primary immune disorders, and/or in subjects who have received treatments to
correct their primary immune disorders. This will be an open label, prospective study
investigating the functional status of the adaptive immune system. Up to 50 subjects may be
enrolled. It is anticipated that subjects will be referred by any investigators at NIH
studying inherited disorders of the immune system under their own protocols.
After giving standard vaccines, we will test specific antibody. The vaccines include licensed
and universally mandated diphtheria and tetanus toxoid, two licensed pneumococcal vaccine
formulations recommended for protection of children from pneumonia, and rabies vaccine
licensed in 1997 (not the formerly available reaction-prone formulation). We will obtain
peripheral blood samples from subjects before vaccination and at a specific time intervals
after vaccination. Measurement of specific antibody titers will be conducted by the
immunology laboratory at the Department of Laboratory Medicin at the NIH. Subjects may be
offered one or more of the vaccines based on available information about their exposure
history and their immune status, and the vaccines may be offered sequentially or in
combination to shorten study time.
While the vaccines used here are often medically indicated and given outside of research
protocols both to provide protection and to assess immune responses, the investigators have
elected to use a protocol for the following reasons:
- Enhancement of subject understanding of the use of vaccines for in vivo assessment of
- Emphasis on the importance of obtaining pre- and post-immunization blood samples to
monitor how well the body's immune system is working.
- Administration of rabies vaccine to subjects who would not ordinarily need it.
- Recognition that vaccine side effects have been widely publicized and may be of concern
to potential enrollees.
- INCLUSION CRITERIA:
Individuals being evaluated by NIH investigators for known or suspected primary immune
Women of childbearing potential and men must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) for at least 21 days prior to receipt of
each vaccine and for the duration of study participation.
Documented HIV infection.
Immunosuppressive therapy, other than steroids.
Symptomatic cardiac disease or ongoing treatment for it.
Pregnant or lactating women (due to restrictions on use of vaccines).
Surgery during the two weeks prior to entry.
Serious, ongoing, or uncontrolled infections.
Platelet count less than 40,000/microL or other coagulation disorder.
Any other major illness that, in the investigator's judgment, may substantially increase
the risk associated with the patient's participation in this study.
History of previous systemic reaction to the particular vaccine product being considered
For RabAvert, persons known to be sensitive to:
- Processed bovine gelatin
- Chicken protein
- Amphotericin B
For Prevnar, persons with know or possible latex sensitivity.